Pre-diltiazem, Calcium Versus Placebo for Atrial Fibrillation With Rapid Ventricular Response

January 11, 2023 updated by: Virginia LaBond MD, Ascension Genesys Hospital

Calcium Administration to Prevent Hypotension Caused by Diltiazem Administration in the Treatment of Atrial Fibrillation With Rapid Ventricular Response

The goal of this randomized double blind controlled trial is to learn about the effects of calcium when it is given prior to diltiazem for patients with atrial fibrillation ( a type of irregular heart beat) who have rapid ventricular response ( a pulse over 100 beats per minute). Normally diltiazem 0.25mg/kg (max 20mg) is given to slow the heart rate. We will give Placebo versus Calcium Gluconate 2gm given prior to diltiazem.

The main questions it aims to answer are:

  • Does calcium decrease the incidence of low blood pressure (a side effect of diltiazem)?
  • How does calcium effect the action of diltiazem? Does it interfere with the desired decrease in heart rate?

Participants will receive either placebo or calcium immediately prior to the administration of diltiazem. Their blood pressure and pulse will be measured:

  • prior to study drug administration
  • post study drug and prior to diltiazem administration
  • 3 minutes post start of diltiazem
  • 5 minutes post start of diltiazem
  • 10 minutes post start of diltiazem
  • 20 minutes post start of diltiazem
  • 30 minutes post start of diltiazem

Researchers will compare the placebo group to the calcium group to see if there is a difference in the blood pressure and pulse.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Diltiazem, a calcium channel blocker is the standard of care for treatment of stable patients with atrial fibrillation and rapid ventricular response. Many emergency physicians opine that calcium, the "antidote" for calcium channel blockers, when given prior to diltiazem administration, mitigates the common adverse effect of hypotension.

In order to obtain evidence related to this belief, we will study the effects of placebo (normal saline 50ml) versus calcium gluconate (2 grams in normal saline 50ml). Hemodynamically stable patients in afib with rvr will be identified on their arrival to the emergency department. Those who consent to the study will be enrolled and the pharmacy will be contacted to provide a blinded study sample to the patient's bedside. After initial vital signs are recorded the study sample will be infused via pump over a 10 minute period. Vitals will be recorded on its completion and a diltiazem bolus (0.25mg/kg, max 20mg) will be administered. Vitals will be recorded at 3, 5, 10, 20 and 30 minutes post start of diltiazem bolus.

The primary outcome of hypotension will be calculated using rates (frequencies). The rate of hypotension will be compared between the two groups using Chi square analysis. The groups will be compared for similarity using means(sd) and frequencies(percentages). Any variables that differ by group will be controlled for with a multiple logistic regression analysis.

A 35% rate of hypotension is estimated for the placebo group and a hypothesized 22% in the treatment group (a relative 37% decrease). This will require a minimum total sample size of 378 (184/ group) . We may terminate the study earlier if we achieve power.

Study Type

Interventional

Enrollment (Anticipated)

378

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Diagnosis of atrial fibrillation with rapid ventricular response (ventricular rate over 100 bpm) due to an electrophysiologic etiology.

-

Exclusion Criteria:

  1. Unstable, requiring electric cardioversion -hypotensive

    • altered mental status
    • myocardial infarction
    • pulmonary hypertension
  2. Patients at risk of hypercalcemia - renal failure
  3. Know cardiac valvular disease
  4. Allergic to calcium gluconate or diltiazem

  5. Underlying cardiac disease - sick sinus syndrome

    • 2nd/3rd degree atrial ventricular block
    • cardiogenic shock
    • recent IV beta blocker administration
    • accession bypass tract (WPW, short PR)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Normal Saline
Normal saline 50 ml intravenous piggyback once over 10 minutes
Drug: Placebo
Patients randomized to placebo group will receive Normal Saline 50ml IV.
Other Names:
  • Normal saline
Experimental: Calcium chloride
x grams in 50 ml ivpb once over 10 minutes
Drug: Calcium
Patients randomized to the study group will receive Calcium 2gm in Normal Saline 50ml IV.
Other Names:
  • Study drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypotension
Time Frame: Thirty minutes from time of drug administration
Mean arterial blood pressure less than 70mm Hg
Thirty minutes from time of drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: Thirty minutes from drug administration
Decrease below 100 beats per minute
Thirty minutes from drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascension Genesys Hospital

Investigators

  • Principal Investigator: Virginia A LaBond, MS MD, Ascension Genesys Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 26, 2023

Primary Completion (Anticipated)

January 31, 2025

Study Completion (Anticipated)

January 31, 2025

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMI20220086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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